Predicate Devices

Reference Devices

AI/ML (Artificial Intelligence / Machine Learning)

No
The summary describes a dental implant made of metal with a specific surface treatment and intended for mechanical support. There is no mention of AI, ML, image processing, or any software-driven analytical capabilities.

Therapeutic

Yes
The device is described as a dental implant system intended to restore chewing function and provide support for prosthetic devices, which falls under the definition of a therapeutic device as it directly treats a physical condition (missing teeth/chewing function).

Diagnostic

No
Explanation: The device, the MS System, is a dental implant designed to support prosthetic devices to restore chewing function. Its purpose is therapeutic/restorative, not diagnostic.

SaMD (Software as a Medical Device)

No

The device description clearly states the MS System is a dental implant made of Ti-6Al-4V metal, indicating it is a physical hardware device, not software.

IVD (In Vitro Diagnostic)

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

Intended Use: The intended use clearly states that the device is a dental implant placed in the bone to support prosthetic devices and restore chewing function. This is a therapeutic and structural function within the body.
Device Description: The device is described as a dental implant made of Ti-6Al-4V metal. This is a physical implant, not a reagent, instrument, or system intended for use in the examination of specimens derived from the human body.
Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting specific substances, or providing diagnostic information about a patient's health status.

IVD devices are used in vitro (outside the body) to examine specimens and provide information for diagnosis, monitoring, or screening. This device is used in vivo (inside the body) for structural support and functional restoration.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

The MS System (Denture) is intended to be place in the bone of the upper or lower jaw arches to provide support the prosthetic devices to restore the patient's chewing function, including the denture stabilization. MS System (Denture) is intended for single use only.

The MS System (Narrow Ridge) is intended to use in the treatment of missing mandibular central and lateral incisors to support prosthetic device, such as artificial teeth, in order to restore chewing function in partially edentulous patients. MS System (Narrow Ridge) is intended for single use only. It is not for immediate load.

Product codes (comma separated list FDA assigned to the subject device)

DZE

Device Description

The MS System is a dental implant made of Ti-6Al-4V metal. The MS System is similar to other commercially available products based on the intended use, the technology used, the claims, the material composition employed and performance characteristics. The surface treatment of MS System is R.B.M (Resorbable Blasting Media).

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

bone of the upper or lower jaw arches, mandibular central and lateral incisors

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Not Found

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

The MS System has been subjected to safety, performance, and product validations prior to release. Safety tests including biocompatibility have been performed to ensure the devices comply with the applicable International and US regulations.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

K072959, K080594

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

K080129

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

Regulation Number and Section

§ 872.3640 Endosseous dental implant.

(a)
Identification. An endosseous dental implant is a prescription device made of a material such as titanium or titanium alloy that is intended to be surgically placed in the bone of the upper or lower jaw arches to provide support for prosthetic devices, such as artificial teeth, in order to restore a patient's chewing function.(b)
Classification. (1) Class II (special controls). The device is classified as class II if it is a root-form endosseous dental implant. The root-form endosseous dental implant is characterized by four geometrically distinct types: Basket, screw, solid cylinder, and hollow cylinder. The guidance document entitled “Class II Special Controls Guidance Document: Root-Form Endosseous Dental Implants and Endosseous Dental Implant Abutments” will serve as the special control. (See § 872.1(e) for the availability of this guidance document.)(2)
Classification. Class II (special controls). The device is classified as class II if it is a blade-form endosseous dental implant. The special controls for this device are:(i) The design characteristics of the device must ensure that the geometry and material composition are consistent with the intended use;
(ii) Mechanical performance (fatigue) testing under simulated physiological conditions to demonstrate maximum load (endurance limit) when the device is subjected to compressive and shear loads;
(iii) Corrosion testing under simulated physiological conditions to demonstrate corrosion potential of each metal or alloy, couple potential for an assembled dissimilar metal implant system, and corrosion rate for an assembled dissimilar metal implant system;
(iv) The device must be demonstrated to be biocompatible;
(v) Sterility testing must demonstrate the sterility of the device;
(vi) Performance testing to evaluate the compatibility of the device in a magnetic resonance (MR) environment;
(vii) Labeling must include a clear description of the technological features, how the device should be used in patients, detailed surgical protocol and restoration procedures, relevant precautions and warnings based on the clinical use of the device, and qualifications and training requirements for device users including technicians and clinicians;
(viii) Patient labeling must contain a description of how the device works, how the device is placed, how the patient needs to care for the implant, possible adverse events and how to report any complications; and
(ix) Documented clinical experience must demonstrate safe and effective use and capture any adverse events observed during clinical use.

Summary

0

K08 3067

FEB - 2 2009

Image /page/0/Picture/2 description: The image shows the logo for OSSTEM. The logo consists of a circular graphic above the word "OSSTEM". The circular graphic is made up of several concentric circles that appear to be slightly distorted, giving it a dynamic, swirling appearance.

OSSTEM Implant Co., Ltd. #507-8 Geoje3-Dong Yeonje-Gu Busan, 611-804 Republic of Korea Tel: +82 51 850-2500 Fax: +82 51 850-4341 www.osstem.com

510(k) Summary

This summary of 510(k) safety and effectiveness information is being submitted in accordance with requirements of 21 CFR Part 807.92.

Date: September 30, 2008

Company and Correspondent making the submission:

Submitter's Name :

OSSTEM Implant Co., Ltd.

Mr. JongHyuk Seo

Address :

#507-8 Geoje3-Dong Yeonje-Gu Busan, 611-804, Republic of Korea

Contact :

Device :

Trade or (Proprietary) Name : Common or usual name :

Classification Name :

MS System Dental Implant Endosseous Dental Implant 21CFR872.3640 Class II DZE

Predicate Device :

MS System (Denture), OSSTEM Implant Co., Ltd. (K072959) MS System (Narrow Ridge), OSSTEM Implant Co., Ltd. (K080594)

Description :

The MS System is a dental implant made of Ti-6Al-4V metal. The MS System is similar to other commercially available products based on the intended use, the technology used, the claims, the material composition employed and performance characteristics. The surface treatment of MS System is R.B.M (Resorbable Blasting Media).

The MS System is substantially equivalent in design, function and intended use to the MS System (Denture) and MS System (Narrow Ridge) of OSSTEM Implant Co., Ltd, (K072959, K080594)

Indication for use :

The MS System (Denture) is intended to be place in the bone of the upper or lower jaw arches to provide support the prosthetic devices to restore the patient's chewing function, including the denture stabilization. MS System (Denture) is intended for single use only.

QS-QI-505-1(Rev.0)

Letter(8.5 X 11in)

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1

osstem

OSSTEM Implant Co., Ltd. #507-8 Geoje3-Dong Yeonje-Gu Busan, 611-804 Republic of Korea Tel. +82 51 850-2500 Fax: +82 51 850-4341 www.osstem.com

The MS System (Narrow Ridge) is intended to use in the treatment of missing mandibular central and lateral incisors to support prosthetic device, such as artificial teeth, in order to restore chewing function in partially edentulous patients. MS System (Narrow Ridge) is intended for single use only. It is not for immediate load.

1. Review :
  The MS System has similar material, indication for use, design and technological characteristics as the predicate device.

The MS System has been subjected to safety, performance, and product validations prior to release. Safety tests including biocompatibility have been performed to ensure the devices comply with the applicable International and US regulations.

7. Conclusion :

Based on the information provided in this premarket notification Osstem concludes that the MS System is safe and effective and substantially equivalent to the predicate device as described herein

QS-QI-505-1(Rev.0)

Letter(8.5 X 11in)

2

Image /page/2/Picture/0 description: The image shows the logo for Osstem. The logo consists of a circular design made up of three curved lines that appear to be intertwined. Below the circular design, the word "osstem" is written in a lowercase sans-serif font.

SSTEM Implant Co., Ltd.

OSSTEM Implant Co., Ltd.
#507-8 Geoje3-Dong Yeonje-Gu Busan, 611-804 Republic of Korea
Tel: +82 51 850-2500 Fax: +82 51 850-4341 www.osstein.com

■ Predicate Devices

| | MS System
(Narrow Ridge) | MS System (Denture) | Secure Implant System |
|-------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510K | K080594 | K072959 | K080129 |
| Design | Image: MS System (Narrow Ridge) | Image: MS System (Denture) | Image: Secure Implant System |
| Intended
Use | The MS System (Narrow
Ridge) is intended to use in the
treatment of missing
mandibular central and lateral
incisors to support prosthetic
device, such as artificial teeth,
in order to restore chewing
function in partially edentulous
patients. MS System (Narrow
Ridge) is intended for single
use only. It is not for immediate
load. | The MS System (Denture) is
intended to be place in the bone
of the upper or lower jaw
arches to provide support the
prosthetic devices to restore the
patient's chewing function,
including the denture
stabilization. MS System
(Denture) is intended for single
use only. | Secure Implant System
(2.5/3.0mm) is designed for
use in dental implant surgery
and is intended for use in a
manner in which the implants
integrate with the bone
(osseointegration). It is
intended to provide immediate
transitional splinting stability
or intrabony long-term
fixation of new or existing
crown, bridge and denture
installations in partially or
fully edentulous patients. |
| Body
Diameter
(D) | 3.0 | 2.0~3.0 | 2.5, 3.0 |
| Length
(mm) | 10.0, 13.0, 15.0 | 10.0, 13.0, 15.0 | 10.0, 12.0, 14.0, 16.0 |
| Surface | RBM | RBM | RBM |
| Material | Titanium alloy Ti-6Al-4V
(ASTM F 136-02A) | Titanium alloy Ti-6Al-4V
(ASTM F 136-02A) | Titanium alloy Ti-6Al-4V
(ASTM F 136-02A) |
| Sterilizat
ion | Radiation Sterile | Radiation Sterile | Radiation Sterile |

QS-QI-505-1(Rev.0)

Letter(8.5 X 11in)

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with its wings spread, along with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular pattern around the eagle. The text is in all caps and is smaller than the eagle symbol.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FEB - 2 2009

Osstem Implant Company, Limited C/O Mr. MinJoo Kim Manager Hiossen, Incorporated 85 Ben Fairless Drive Fairless, Pennsylvania 19030

Re: K083067

Trade/Device Name: MS System Regulation Number: 872.3640 Regulation Name: Endosseous Dental implant Regulatory Class: II Product Code: DZE Dated: January 7, 2009 Received: January 12, 2009

Dear Mr. Kim:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

4

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours.

Anthony D. Watson for
Ginette Y. Michaud, M.D.

Acting Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Image /page/5/Picture/0 description: The image shows the Osstem logo. The logo consists of a circular graphic above the word "osstem". The circular graphic appears to be a stylized representation of a tooth or dental implant. The word "osstem" is written in a simple, sans-serif font.

a

510(k) Number K _

Device Name: MS System

Indication for use : The MS System (Denture) is intended to be place in the bone of the upper or lower jaw arches to provide support the prosthetic devices to restore the patient's chewing function, including the denture stabilization. MS System (Denture) is intended for single use only.

The MS System (Narrow Ridge) is intended to use in the treatment of missing mandibular central and lateral incisors to support prosthetic device, such as artificial teeth, in order to restore chewing function in partially edentulous patients. MS System (Narrow Ridge) is intended for single use only. It is not for immediate loading.

Prescription Use X (Per 21CFR801 Subpart D) OR Over-The-Counter Use (Per 21CFR807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Susan Reaser

(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices

510(k) Number:

Letter(8.5 X 11in)

QS-QI-505-1(Rev.0)